đź“‹ FDA Reference
Long-Term Hemodialysis Catheters with Biobloc Coating
Summary: The long-term hemodialysis catheters with biobloc coating by Bard Access Systems are used for hemodialysis in patients requiring long-term vascular access. They are typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053589 ↗
Decision Date ?
April 13, 2006
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on April 13, 2006. Manufactured by Bard Access Systems, it is classified as a Class 2 medical device under product code MSD.
What It Is
The long-term hemodialysis catheters with biobloc coating are specialized catheters designed for patients who require prolonged vascular access for hemodialysis. The biobloc coating is intended to reduce the risk of infection and improve the longevity of the catheter. These catheters are inserted into large veins, typically in the neck or chest, to facilitate efficient blood flow during dialysis sessions.
FDA-Cleared Indications
- Provide long-term vascular access for hemodialysis.
- Use in patients who require ongoing hemodialysis and need a central venous catheter for dialysis access.
Clinical Applications
- Tunneled central venous access for repeated hemodialysis sessions.
- Hemodialysis access when an arteriovenous fistula or graft is not available or cannot be used.
- Access for dialysis treatment in patients with end-stage renal disease who require long-term vascular access.
Practical Considerations
- Catheter length and diameter are selected according to the patient’s anatomy, access vein, and dialysis flow requirements.
- Common access sites include the internal jugular vein, with the catheter tunneled under the skin to a chest exit site; femoral access may be used in selected circumstances.
- The catheter must be placed using sterile technique and imaging guidance when appropriate, then connected to compatible hemodialysis equipment.
- Potential complications include bloodstream infection, catheter-related thrombosis, bleeding, venous stenosis, malposition, and inadequate dialysis flow.
- MRI compatibility and conditions depend on the specific catheter model and labeling; the exact product instructions should be checked before MRI.
Frequently Asked Questions
What is long-term hemodialysis catheters with biobloc coating used for?
These catheters are used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use these catheters, often in dialysis centers or hospital settings.
What are the FDA-cleared indications?
The catheters are indicated for long-term vascular access for hemodialysis in patients with end-stage renal disease.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.